Note: This document contains side effect information about glyburide / metformin. Some dosage forms listed on this page may not apply to the brand name Glucovance.

Summary

Common side effects of Glucovance include: diarrhea. Continue reading for a comprehensive list of adverse effects.

Applies to glyburide / metformin: oral tablet.

Serious side effects of Glucovance

Along with its needed effects, glyburide / metformin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking glyburide / metformin:

More common

• Anxious feeling
• behavior change similar to being drunk
• blurred vision
• cold sweats
• confusion
• convulsions (seizures)
• cool, pale skin
• cough
• difficulty with concentrating
• drowsiness
• excessive hunger
• fast heartbeat
• fever
• headache (continuing)
• nausea
• nervousness
• nightmares
• restless sleep
• shakiness
• slurred speech
• sneezing
• sore throat
• unconsciousness
• unusual tiredness or weakness

Rare

• Abdominal or stomach discomfort
• decreased appetite
• diarrhea
• fast shallow breathing
• general feeling of discomfort
• muscle pain or cramping
• unusual sleepiness

Other side effects of Glucovance

Some side effects of glyburide / metformin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Dizziness
• headache
• vomiting

For Healthcare Professionals

Applies to glyburide / metformin: oral tablet.

General

The most commonly reported adverse reactions include hypoglycemia, upper respiratory infection, gastrointestinal events, and dizziness.^[Ref]

Metabolic

In clinical trials, all hypoglycemic episodes were managed by patients, no episodes required medical intervention or pharmacologic therapy. The incidence of hypoglycemia was highest in patients with a baseline HbA1c less than 7%. For patients with a baseline HbA1c between 8% and 11% receiving glyburide 2.5 mg-metformin 500 mg as initial therapy, the frequency of hypoglycemic symptoms was 30% to 35%. As second-line therapy in patients inadequately controlled on a sulfonylurea alone, 6.8% of patients experienced hypoglycemic episodes. The addition of rosiglitazone resulted in 22% of patients reporting a fingerstick glucose measurement of 50 mg/DL or lower (compared to 3.3% of placebo patients). Additionally in rosiglitazone-treated patients, a mean weight gain of 3 kg was observed.

Metabolic side effects, including lactic acidosis, which is a potentially fatal metabolic complication of biguanide therapy, has been reported in patients receiving metformin. The incidence of lactic acidosis has been about 0.03 cases per 1,000 patient years with approximately 0.015 fatal cases per 1,000 patient-years. The risk of lactic acidosis is particularly high in patients with underlying renal insufficiency. Cases of lactic acidosis occurring in patients with normal renal function have been rarely reported. Concomitant cardiovascular or liver disease, sepsis, and hypoxia may also increase the risk of lactic acidosis.

Glyburide-Metformin:

Very common (10% or more): Hypoglycemia (up to 37.7%)

Very rare (less than 0.01%): Disulfiram-like reactions

Frequency not reported: Weight gain, hypoglycemic coma, elevated blood glucose level, dehydration, metabolic acidosis

Glyburide:

Very common (10% or more): Hypoglycemia (21.3%)

Very rare (less than 0.01%): Disulfiram-like reactions, hyponatremia

Frequency not reported: Moderate elevations in serum urea and creatinine concentrations

Metformin:

Common (1% to 10%): Hypoglycemia

Rare (less than 0.1%): Lactic acidosis

Gastrointestinal

The incidence of gastrointestinal (GI) side effects including diarrhea, nausea/vomiting, and abdominal pain in the initial therapy trials were 31.6% (50/158) and 38.3% (n=62/162) in the glyburide 1.25 mg-metformin 250 mg and the glyburide 2.5 mg-metformin 500 mg groups, respectively. Across all trials, GI symptoms were the most common adverse event and were more frequent at higher dose levels; less than 2% of patients discontinued therapy due to GI adverse events.^[Ref]

Glyburide-Metformin:

Very common (10% or more): Diarrhea (17%)

Common (1% to 10%): Nausea/vomiting, abdominal pain

Frequency not reported: Pancreatitis, acute gallstone pancreatitis, gastrointestinal hemorrhage^[Ref]

Hematologic

Glyburide-Metformin:

Frequency not reported: Disseminated intravascular coagulation, hemorrhage

Glyburide:

Rare (less than 0.1%): Agranulocytosis, eosinophilia, hemolytic anemia, aplastic anemia, bone marrow aplasia, pancytopenia, coagulation disorders

Frequency not reported: Leukopenia, thrombocytopenia, thrombocytopenia purpura

Postmarketing reports: Hemolytic anemia in patients not known to have G6PD deficiency

Metformin:

Common (1% to 10%): Subnormal vitamin B12 levels

Frequency not reported: Anemia^[Ref]

Respiratory

Glyburide-Metformin:

Very common (10% or more): Upper respiratory infection (17.3%)

Frequency not reported: Pulmonary hypertension^[Ref]

Nervous system

Glyburide-Metformin:

Common (1% to 10%): Headache, dizziness

Frequency not reported: Dystonia, involuntary muscle contractions, grand mal seizure, unconsciousness, unresponsiveness

Glyburide:

Frequency not reported: Paresthesia, tremor, convulsions, encephalopathy, cerebrovascular disorders, headache,

Metformin:

Common (1% to 10%): Taste disturbances^[Ref]

Dermatologic

Glyburide-Metformin:

Frequency not reported: Dermatitis

Glyburide:

Common (1% to 10%): Pruritus, erythema, urticaria erythematous, maculopapular rash and bullous skin eruptions or psoriasiform drug eruption

Frequency not reported: Alopecia/hypotrichosis, angioedema, facial edema, increased sweating

Sulfonylureas:

Very rare (less than 0.01%): cutaneous or visceral allergic angitis, exfoliative dermatitis, urticaria evolving to shock

Frequency not reported: Porphyria cutanea tarda, pellagra-like changes, photosensitization

Metformin:

Rare (less than 0.1%): Skin reactions such as erythema, pruritus and urticaria^[Ref]

Hypersensitivity

Sulfonylureas:

Frequency not reported: Cross-reactivity to sulfonamide(s) and their derivatives^[Ref]

Hepatic

Glyburide-Metformin

Frequency not reported: Cholethiasis

Metformin:

Very rare (less than 0.01%): Liver function test abnormalities, hepatitis

Postmarketing reports: Cholestatic jaundice

Sulfonylureas:

Frequency not reported: Hepatic porphyria, increased liver enzymes (AST, ALT), abnormal liver function, cholestasis, cholestatic hepatitis, granulomatous hepatitis, and bilirubinemia^[Ref]

Renal

Glyburide-Metformin:

Frequency not reported: Acute renal failure

Glyburide:

Frequency not reported: Abnormal renal function, acute renal failure^[Ref]

Ocular

Glyburide:

Frequency not reported: Transient visual disturbances at the start of treatment (due to decrease in glycemic levels), blindness, diplopia, visual disturbances, ocular disturbances (accommodation changes, crystalline lens changes)^[Ref]

Cardiovascular

Glyburide-Metformin:

Common (1% to 10%): Edema

Frequency not reported: Myocardial infarction, tachycardia, chest pain^[Ref]

In add-on rosiglitazone clinical trials, edema was reported in 7.7% (14/181) patients compared to 2.2% in placebo patients.^[Ref]

Endocrine

Glyburide:

Frequency not reported: Syndrome of inappropriate secretion of antidiuretic hormone (SIADH)^[Ref]

Musculoskeletal

Glyburide:

Frequency not reported: Arthralgia, arthritis^[Ref]

Psychiatric

Glyburide-Metformin:

Frequency not reported: Disorientation

Glyburide:

Frequency not reported: Confusion, acute psychosis^[Ref]

Other

Glyburide:

Frequency not reported: Deafness^[Ref]